Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
Detailed Description
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
- •The patient meets criteria as set out in the national SPC for escitalopram
- •The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs
Exclusion Criteria
- •The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
- •The patient has contraindications to escitalopram
- •The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
- •The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
- •The patient is pregnant or breast-feeding
- •The patient, if a woman of childbearing potential, is not using adequate contraception
Arms & Interventions
Escitalopram
Intervention: Escitalopram
Outcomes
Primary Outcomes
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
Time Frame: baseline and 8 weeks
The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.
Secondary Outcomes
- Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)(baseline and 8 weeks)
- Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2(baseline and 8 weeks)
- Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social(baseline and 8 weeks)
- Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score(baseline and 8 weeks)